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U.S. Department of Health and Human Services

Class 2 Device Recall

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 Class 2 Device Recallsee related information
Date Initiated by FirmNovember 25, 2003
Date PostedJanuary 01, 2004
Recall Status1 Terminated 3 on December 06, 2006
Recall NumberZ-0291-04
Recall Event ID 27954
510(K)NumberK013825 K022884 K030834 K030846 
Product Classification Powered Laser Surgical Instrument - Product Code GEX
ProductCandela Smoothbeam Laser System Model Numbers: 9914-00-0820 9914-06-0820 9914-07-0820 9914-08-0820 9914-10-0820 Units are the same except for color
Code Information Serial Numbers:  9914-0820-0101 thru 9914-0820-0602 9914-0820-P2 9914-0820-P4 9914-0820-P5 9914-0820-P6
FEI Number 1218402
Recalling Firm/
Manufacturer		 Candela Laser Corporation
530 Boston Post Rd
Wayland MA 01778-1833
For Additional Information ContactEd Gramer
508-358-7637 Ext. 229
Manufacturer Reason
for Recall		Laser may pulse and not dispense cryogen resulting in patient injury
FDA Determined
Cause 2		Other
ActionCandela notified direct customers and distributors by letter dated 11125/03 and issued Certified Mail. Accounts are requested to perform two tests on the unit to determine if the unit has the problem. If a unit fails, Candela's Field Service will make the repair. Distributors are requested to notify their customers.
Quantity in Commerce506 units
DistributionNationwide Foreign: Canada,Thailand, Germany, Spain , Japan, Italy, Greece, Saudi Arabia, UK, France, Switzerland, Mexico, Ukraine, Kuwait, Netherlands.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = GEX
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